New Concepts in Diabetic Macular Edema (DME)

Not Applicable

Completed

• Conditions: Diabetes Mellitus, With Complications
• Interventions: Procedure: INTRAVITREAL RANIBIZUMAB INJECTION

• Registration Number: NCT04186702
• Lead Sponsor: Ain Shams University

Brief Summary

Intravitreal ranibizumab injection procedure is simple and effective. In management of chronic DME there is no clear anatomical endpoint. Visual stability is the primary aim. Argon focal laser therapy can be the safe second choice. The combined therapy is successful and practical for chronic DME patients.

Detailed Description

Settings and Design: Randomized clinical study

Subjects and Methods:

investigators randomly assigned 150 adults (the average age was 59.32 years ±2.79) with chronic diabetic macular edema involving the macular center for repeated ranibizumab injections (group A-75) or focal/direct argon laser after repeated ranibizumab injections (group B-75). The outcomes were the changes in visual acuity letter score and the central subfield thickness (CST) from baseline to one year. visual-acuity Letter score, and CST were analyzed with independent t-test and Mann Whitney-test. General linear model with multivariate analysis was used for visual acuity letter score, and CST in both groups.

Study Timeline

• Study Start: 2014-09-10
• Primary Completion: 2016-10-01
• Study Completion: 2017-09-09
• Study First Submitted: 2019-11-30
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-04
• Last Update Submitted: 2019-12-04
• Study First Posted: 2019-12-05
• Last Update Posted: 2019-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• focal maculopathy
• diffuse macular edema
• diffuse macular edema with ischemic changes

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Exclusion Criteria

• ischemic maculopathy that was associated with grades of non-proliferative changes, or capillary drop out zones presented in the periphery of the macula
• patients with history of stroke or transient ischemic attack
• hypersensitivity to ranibizumab or any component of the ranibizumab formulation
• uncontrolled glaucoma in either eye (intraocular pressure [IOP] >24 mmHg with medication)
• evidence of vitreomacular traction (in either eye)
• active proliferative diabetic retinopathy (study eye)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
macular thickness(CST)	INTRAVITREAL RANIBIZUMAB INJECTION	macular thickness(CST)is used to compare between the two groups after interventional procedures
visual acuity letter score	INTRAVITREAL RANIBIZUMAB INJECTION	visual acuity letter score is used to compare between the two groups after interventional procedures

Primary Outcome Measures

Name	Time	Method
visual acuity letter score	one-year follow up	The visual acuity letter score at one-year
central subfield thickness (CST)	one-year follow up	the mean CST observed at one-year

Secondary Outcome Measures

Name	Time	Method
patient compliant-complications	one-year follow up	subjective symptoms